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Highlights

  • FDA grants PMA approval following 316-patient pivotal trial with 0.95% 30-day adverse event rate.
  • CGuard Prime shows 1.93% one-year major adverse events lowest recorded in carotid stent trials.
  • U.S. approval supports expansion of minimally invasive stroke prevention technologies.

InspireMD, Inc. (Nasdaq: NSPR), a medical technology company focused on stroke prevention, has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its CGuard Prime Carotid Stent System. The approval allows the commercial launch of the device in the U.S. for treating carotid artery stenosis, a condition that can lead to stroke. 

The FDA’s decision is based on clinical results from the C-GUARDIANS pivotal trial, which enrolled 316 patients across 24 clinical sites in the U.S. and Europe. The trial evaluated the safety and efficacy of CGuard Prime in patients at high risk for carotid endarterectomy. The system achieved a 0.95% 30-day major adverse event rate (stroke, death, myocardial infarction) and a 1.93% event rate at one year metrics that rank among the lowest reported in major carotid stenting trials. 

The stent system is designed with MicroNet™ mesh technology, intended to prevent post-procedural embolic events, a common complication in carotid interventions. The approval positions CGuard Prime as a treatment option for symptomatic and asymptomatic patients with carotid artery disease ineligible for or at higher risk from surgery. 

Dr. D. Chris Metzger, the U.S. principal investigator of the trial, emphasized that the study demonstrated the lowest stroke, death, and myocardial infarction rates seen in any pivotal carotid revascularization trial. These results are particularly significant given that one-fourth of the trial’s patient population was symptomatic. 

With over 65,000 implants already sold internationally and clinical studies covering more than 2,000 patients, the company intends to begin commercial rollout in the United States immediately. This move marks an expansion of carotid revascularization options toward less invasive methods in a regulated U.S. market. 

The approval underscores a shift in clinical practice toward stenting solutions that combine procedural safety with post-operative protection, potentially influencing treatment strategies for high-risk vascular patients nationwide.